Food and Drug Administration (FDA) is issuing an exemption from the enhanced drug distribution security requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act, through the Drug Supply Chain Security Act, for eligible trading partners. This exemption applies to any product transacted by eligible trading partners (who have successfully completed or made documented efforts to complete data connections with their immediate trading partners but still face challenges exchanging data).
This exemption is part of the agency’s broader efforts to avoid supply chain disruptions and ensure that patients will not face delays in receiving the medicines they need.
The duration of the exemption varies depending on the eligible trading partners:
- Manufacturers and repackagers: May 27, 2025
- Wholesale distributors: August 27, 2025
- Dispensers with 26 or more full-time employees: November 27, 2025
Trading partners who utilize these exemptions do not need to notify FDA.